Large bore anchor device

ABSTRACT

A vascular closure system includes a suture and an anchor assembly. The anchor assembly includes a first anchor portion having a plurality of petal members automatically expandable from a retracted position for delivery through a vessel puncture in a vessel, and an expanded position when deployed within the vessel. The anchor assembly also includes a second anchor portion connected to the suture and positioned distal of the first anchor portion within the vessel. Withdrawing the suture pulls the second anchor portion against the first anchor portion to contact the first anchor portion against an inner surface of the vessel adjacent to the vessel puncture. The vascular closure system may also include an automatic compaction assembly that automatically compacts a sealing member against the anchor assembly to seal closed the vessel puncture upon withdrawal of the vascular closure system.

CROSS REFERENCE RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.13/682,575, filed on 20 Nov. 2012, now pending, which claims the benefitof U.S. Provisional App. No. 61/564,237, filed on 28 Nov. 2011, thedisclosures of which are incorporated, in their entireties, by thisreference.

TECHNICAL FIELD

The present disclosure relates to closure devices, and more specificallyrelates to closure devices that seal closed a tissue puncture such as avascular puncture.

BACKGROUND

Various surgical procedures are routinely carried out intravascularly orintraluminally. For example, in the treatment of vascular disease, suchas arteriosclerosis, it is a common practice to invade the artery andinsert an instrument (e.g., a balloon or other type of catheter) tocarry out a procedure within the artery. Such procedures usually involvethe percutaneous puncture of the artery so that an insertion sheath maybe placed in the artery and thereafter instruments (e.g., catheter) maypass through the sheath and to an operative position within the artery.Intravascular and intraluminal procedures unavoidably present theproblem of stopping the bleeding at the percutaneous puncture after theprocedure has been completed and after the instruments (and anyinsertion sheaths used therewith) have been removed. Bleeding frompuncture sites, particularly in the case of femoral arterial punctures,is typically stopped by utilizing vascular closure devices, such asthose described in U.S. Pat. Nos. 6,090,130 and 6,045,569, which arehereby incorporated in their entireties by this reference.

Typical closure devices such as the ones described in theabove-mentioned patents place sealing material at the tissue puncturesite. Successful deployment of the sealing material includes ejectionfrom within the closure device sheath to a location adjacent to thetissue puncture along an outer surface of the vessel. Failure to contactthe sealing material against the outer surface of the vessel may alsoresult in an improper seal.

Intravascular devices typically include an intravascular component(e.g., anchor) used to create a compressive sealing force between theinner wall of the artery and the exterior device. The opposite appliedforce from the intravascular component helps place the sealing materialin alignment with the tissue puncture and obtain a proper seal. Theintravascular component may be permanently positioned within the vessel.to help maintain tension that holds the sealing material in place tomaintain the seal. There are challenges involved in providing anintravascular component that is small enough for delivery through thetissue puncture while still being large enough to provide properanchoring within the vessel. Other challenges exist related tomaintaining a position of the intravascular component in contact with aninner surface of the vessel, and connecting the intravascular componentto the sealing material,

SUMMARY

One aspect of the present disclosure relates to a vascular closuresystem that includes a suture and an anchor assembly. The anchorassembly includes a first anchor portion having a plurality of petalmembers automatically expandable from a retracted position for deliverythrough a vessel puncture in a vessel, and an expanded position whendeployed within the vessel. The anchor assembly also includes a secondanchor portion connected to the suture and positioned distal of thefirst anchor portion within the vessel. Withdrawing the suture pulls thesecond anchor portion against the first anchor portion to contact thefirst anchor portion against an inner surface of the vessel adjacent tothe vessel puncture.

The plurality of petal members may be oriented perpendicular to alongitudinal dimension of the anchor assembly when in the expandedposition. The plurality of petal members may extend proximally when inthe retracted position. The plurality of petal members may pivot in asingle direction from the expanded position to the retracted position.The plurality of petal members may each include a living hinge. Thefirst anchor portion may include an aperture defined by a first taperedsurface, and the second anchor portion may include a second taperedsurface that contacts the first tapered surface.

The first and second anchor portions may be separate and distinctpieces. The second anchor portion may include a suture through holeconfigured for connecting the suture to the second anchor portion. Atleast some of the plurality of petal members may include a sutureaperture configured to pass a suture therethrough. The plurality ofpetal members may include a stiffening rib.

Another aspect of the present disclosure relates to a vascular closuredevice that includes a suture, a two-piece anchor assembly, and asealing member. The anchor assembly includes a first anchor portionhaving a plurality of petal members that pivot into an expanded positionupon positioning in a vessel, and a second anchor portion connected tothe suture and configured to draw the first anchor portion against aninner surface of the vessel upon withdrawal of the second anchorportion. The sealing member is configured to advance along the sutureand be compacted against the anchor assembly to seal closed a vesselpuncture.

The plurality of petal members may each include a hinge portion. Theplurality of petal members may each include a neck portion and a petalportion, wherein the neck portion has a smaller maximum width than amaximum width of the petal portion. The first anchor portion maycomprise a shape memory material. The first anchor portion may have alarger profile when in the expanded position than a profile of thesecond anchor portion.

A further aspect of the present disclosure relates to a method ofclosing an opening in a wall of a vessel. The method includes providingan anchor assembly, a suture, and a sealing member, wherein the anchorassembly includes a first anchor member having a plurality of petalsmovable between expanded and retracted positions, and a second anchormember connected to the suture. The method also includes advancing theanchor assembly through the vessel opening and into the vessel, movingthe plurality of petals into the expanded position, retracting thesecond anchor member to draw the first anchor member against an innersurface of the vessel wall, and advancing the sealing member to thevessel opening to seal closed the vessel puncture.

Moving the plurality of petals into the expanded position may occurautomatically upon deploying the first anchor member within the vessel.The method may include providing a carrier tube and positioning theanchor assembly within the carrier tube for delivery into the vessel.The method may include pivoting the plurality of petals proximally intoa retracted position before advancing the anchor assembly through thevessel opening. The method may include pivoting the plurality of petalsthrough an angle of no greater than 100° between the expanded andretracted positions.

The foregoing and other features, utilities, and advantages of theinvention will be apparent from the following detailed description ofthe invention with reference to the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a partial cut-away side view of a tissue puncture closuredevice according to the prior art.

FIG. 2 is a side view of the tissue puncture closure device of FIG. 1engaged with an artery according to the prior art.

FIG. 3 is a side view of the tissue puncture closure device of FIG. 1being withdrawn from a vessel according to the prior art to deploy asealing plug.

FIG. 4 is a side view of the tissue puncture closure device of FIG. 1illustrating compaction of the sealing plug according to the prior art.

FIG. 5 is an exploded perspective view of an example tissue punctureclosure device in accordance with the present disclosure.

FIG. 6 is a cross-sectional side view of a distal end of the tissuepuncture closure device of FIG. 5 inserted through a tissue puncture.

FIG. 7 is a cross-sectional side view of the distal end of the tissuepuncture closure device of FIG. 6 with an anchor assembly deployed.

FIG. 8 is a cross-sectional side view of the tissue puncture closuredevice of FIG. 7 with the anchor assembly drawn into contact with aninner surface of the tissue.

FIG. 9 is a cross-sectional side view of the tissue puncture closuredevice of FIG. 8 with a sealing member compacted against the anchorassembly.

FIG. 10 shows the tissue puncture of FIGS. 6-9 sealed closed.

FIG. 11 is a front view of a first anchor portion of the anchor assemblyof FIGS. 6-10.

FIG. 12 is a rear view of a first anchor portion of the anchor assemblyof FIGS. 6-10.

FIG. 13 is a cross-sectional view of the first anchor portion of FIG. 12taken along cross section indicators 13-13.

FIG. 14 is a perspective view of a petal member of the first anchorportion of FIGS. 11-13.

FIG. 15 is a rear view of another example first anchor portion of ananchor assembly in accordance with the present disclosure.

FIG. 16 is a rear view of another example first anchor portion of ananchor assembly in accordance with the present disclosure.

FIG. 17 is a cross-sectional view of the first anchor portion of FIG. 16taken along cross section indicators 17-17.

FIG. 18 is a perspective view of a second anchor portion of the anchorassembly of FIGS. 5-10.

FIG. 19 is a rear view of the second anchor portion of FIG. 18.

FIG. 20 is a side view of the second anchor portion of FIG. 18.

DETAILED DESCRIPTION

The systems disclosed herein may be used to close or seal percutaneouspunctures made through the body tissue of a patient to gain access to abody cavity of a patient. Access through these percutaneous puncturesallows a physician to carry out various procedures in or through thebody cavity for examination, surgery, treatment and the like. While notintended to be limiting, the systems are illustrated being used to sealpercutaneous punctures that provide access to blood vessels in patientsfor various procedures. It will be appreciated that the systems areapplicable to other procedures requiring sealing of a puncture throughbody tissue into a cavity including, for example, laparoscopic surgeryand other microscopic surgery techniques using a relatively smallincision.

As used in this specification and the appended claims, the terms“compact,” “compaction,” and “compacting” are used broadly to meanpacking down and compressing by one or a succession of blows or taps orsmooth, steady pressure, but not by excessive force. The terms “tamp”and “tamping” may relate to certain types or forms of “compaction” and“compacting.” “Engage” and “engagable” are also used broadly to meaninterlock, mesh, or contact between two devices. Likewise “disengage” or“disengagable” means to remove or capable of being removed frominterlock, mesh, or contact. A “tube” is an elongated device with apassageway. The passageway may be enclosed or open (e.g., a trough). A“lumen” refers to any open space or cavity in a bodily organ, especiallyin a blood vessel. The words “including” and “having,” as used in thespecification, including the claims, have the same meaning as the word“comprising.”

The general structure and function of tissue closure devices used forsealing a tissue puncture in an internal tissue wall accessible throughan incision in the skin are well known in the art. Applications ofclosure devices including those implementing principles described hereininclude closure of a percutaneous puncture or incision in tissueseparating two internal portions of a living body, such as punctures orincisions in blood vessels, ducts or lumens, gall bladders, livers,hearts, etc. While the vascular instruments shown and described belowinclude puncture closure devices, the application of principlesdescribed herein are not limited to the specific devices shown. Theprinciples described herein may be used with any medical device.Therefore, while the description below is directed primarily to arterialprocedures and certain embodiments of a tissue puncture closure device,the methods and apparatus are only limited by the appended claims.

The present disclosure is directed to a closure device that places ananchor assembly through a tissue puncture in a tissue layer to assist insealing closed the tissue puncture. In one embodiment, the anchorassembly includes at least two components, wherein a first of thecomponents includes a plurality of extendable petal members and a secondof the components is configured as a plug structure that draws the firstcomponent against an inner surface of the tissue layer. The tissuepuncture may be a large bore opening sized at least 10 French. Thepresent disclosure contemplates that a medical procedure will beperformed through a sheath that is inserted through the tissue puncturein the tissue layer (e.g., vessel wall). The sheath provides access tothe inside of the tissue layer. After completion of the medicalprocedure and removal of the sheath, the closure device positions theanchor assembly through the tissue puncture to provide an anchoringfunction on one side of the tissue puncture, and positions a sealingmember on an opposite side of the tissue puncture to seal closed thetissue puncture.

The petal members of the anchor assembly are movable from a retractedposition that provides a reduced profile during delivery of the anchorassembly through the tissue puncture, to an expanded position thatprovides an enlarged profile to assist in providing an anchoringfunction. The petal members may automatically move from the retractedposition to the expanded position upon being released or deployed oncethrough the tissue puncture. The petal members may retract in a proximaldirection. The petal members, when in the expanded position, may extendgenerally perpendicular to a longitudinal axis of the anchor assembly.The petal members may pivot about hinge members between the retractedand extended positions. The hinge members may include living hinges andbe formed integrally with other portions of the first component of theanchor assembly. The petal members may include stiffening members suchas at least one rib that, for example, extends around a periphery of thepetal member.

Referring to FIGS. 1-4, a tissue puncture closure device 100 is shownaccording to the prior art. Some example closure devices are disclosedin U.S. Pat. Nos. 7,931,670; 7,618,438; and 7,618,436, which referencesare incorporated herein in their entireties by this reference. Thetissue puncture closure device 100 includes a carrier tube 102 with afilament or suture 104 extending at least partially therethrough. Thetissue puncture closure device 100 also includes a first or proximal end106 and a second or distal end 107. External to the distal end 107 ofthe carrier tube 102 is an anchor 108. The anchor may include anelongated, stiff, low profile member including an eye 109 formed at themiddle. The anchor 108 is typically made of a biologically resorbablepolymer.

The suture 104 is threaded through the anchor 108 and back to a collagenpad 110. The collagen pad 110 may comprise, for example, randomlyoriented fibrous material bound together by chemical means. The collagenpad 110 is slidingly attached to the suture 104 as the suture passesdistally through the carrier tube 102. As the suture traverses theanchor 108 and reenters the carrier tube 102, the suture 104 is securelyslip knotted proximal to the collagen pad 110 to facilitate cinching ofthe collagen pad 110 when the tissue puncture closure device 100 isproperly placed and the anchor 108 deployed (see FIG. 4).

The carrier tube 102 typically includes a compaction member 112 disposedtherein, The compaction member 112 is slidingly mounted on the suture104 and may be used by an operator to compact the collagen pad 110toward the anchor 108 at an appropriate time to seal a percutaneoustissue puncture.

Prior to deployment of the anchor 108 within an artery, the eye 109 ofthe anchor 108 rests outside the distal end 107 of the carrier tube 102.The anchor 108 may be temporarily held in place flush with the carriertube 102 using a bypass tube 114 that is disposed over the distal end107 of the carrier tube 102.

The flush arrangement of the anchor 108 and carrier tube 102 allows theanchor 108 to be inserted into a sheath such as insertion sheath 116 asshown in FIGS. 2-4, and eventually through a tissue (e.g., arterial)puncture 118. The insertion sheath 116 is shown in FIGS. 2-4 insertedthrough a percutaneous incision 119 and into an artery 128. The bypasstube 114 (see FIG. 1) includes an oversized head 120 that prevents thebypass tube 114 from passing through an internal passage of theinsertion sheath 116. As the tissue puncture closure device 100 isinserted into the insertion sheath 116, the oversized head 120 bearsagainst a surface 122 of insertion sheath 116.

Further insertion of the tissue puncture closure device 100 results insliding movement between the carrier tube 102 and the bypass tube 114,thereby releasing the anchor 108 from the bypass tube 114 (see FIG. 1).The anchor 108 typically remains in the flush arrangement shown in FIG.1 following release from the bypass tube 114, limited in movement by theinsertion sheath 116.

The insertion sheath 116 may include a monofold 124 at a second ordistal end 126 thereof The monofold acts as a one-way valve to theanchor 108. A monofold is typically a plastic deformation in a portionof the insertion sheath 116 that elastically flexes as the anchor 108 ispushed out through the distal end 126 of the insertion sheath 116.Typically, after the anchor 108 passes through the distal end 126 of theinsertion sheath 116 and enters the artery 128, the anchor 108 is nolonger constrained to the flush arrangement with respect to the carriertube 102 and it deploys and rotates to the position shown in FIG. 2.

The insertion sheath 116 may include a pair of closure device connectionapertures (not shown) and a carrier tube aperture (not shown) at aproximal surface see FIG. 1). The carrier tube 102 is inserted into thecarrier tube aperture and the sheath connection members 130 are insertedinto and releasably engage with the closure device connection apertureswhen assembling the tissue puncture closure device 100 with theinsertion sheath 116.

Referring next to FIGS. 34, with the anchor 108 deployed, the tissuepuncture closure device 100 and the insertion sheath 116 are withdrawntogether, ejecting the collagen pad 110 from the carrier tube 102 intothe percutaneous incision 119 and exposing the compaction member 112.With the compaction member 112 fully exposed as shown in FIG. 4, thecollagen pad 110 is manually compacted, and the anchor 108 and collagenpad 110 are cinched together and held in place with the self-tighteningslip-knot on the suture 104. The tissue puncture is sandwiched betweenthe anchor 108 and the collagen pad 110, thereby sealing the tissuepuncture 118. The suture 104 is then cut and the percutaneous incision119 may be closed. The suture 104, anchor 108, and collagen pad 110 aregenerally made of resorbable materials and therefore remain in placewhile the tissue puncture 118 heals.

It may be difficult to eject and compact the collagen pad 110 using thetypical tissue puncture closure device 100 described above. Theinsertion sheath 116 resists deformation as the collagen pad 110 isejected from the carrier tube and compaction does not commence until theinsertion sheath 116 has been removed so as to expose the compactionmember 112 for manual grasping. Under certain conditions, removal of theinsertion sheath 116 prior to compacting the collagen pad 110 causes thecollagen pad 110 to retract or displace proximally from the tissuepuncture 118, creating an undesirable gap between. the collagen pad 110and the tissue puncture 118.

Referring now to FIGS. 5-14 and 18-20, an apparatus, for example atissue puncture closure device 200, is shown according to one embodimentof the present disclosure. The closure device 200 is shown as anassembly in the exploded perspective view of FIG. 5. FIGS. 6-10illustrate the closure device 200 inserted through a procedure sheath216 and into a vessel 128. FIGS. 11-14 illustrate details of a firstportion of an anchor assembly of the closure device 200. FIGS. 15-17show alternative embodiments of the first portion of the anchorassembly. FIGS. 18-20 illustrate details of a second portion of theanchor assembly of the closure device 200.

The closure device 200 has particular utility when used in connectionwith intravascular procedures, such as angiographic dye injection,cardiac catheterization, balloon angioplasty and other types ofrecanalizing of atherosclerotic arteries, etc. as the closure device 200is designed to cause immediate hemostasis of the blood vessel (e.g.,arterial) puncture. However, it will be understood that while thedescription of the preferred embodiments below are directed to thesealing off of percutaneous punctures in arteries, such devices havemuch more wide-spread applications and can be used for sealing puncturesor incisions in other types of tissue walls as well. Thus, the sealingof a percutaneous puncture in an artery, shown herein, is merelyillustrative of one particular use of the closure device 200 accordingto principles of the present disclosure.

The closure device 200 includes carrier tube 202 designed for insertionthrough the procedure sheath 216. The carrier tube 202 is used todeliver components of the closure device 200 through the tissue puncture118 and into the vessel 128. The procedure sheath 216 is designed forinsertion through the percutaneous incision 119 in a tissue layer andthrough the tissue puncture 118 into the vessel 128. The vessel includesan inner surface 129.

Referring now to FIGS. 5-14, an example tissue puncture closure device200 is shown and described. The tissue puncture closure device 200includes a carrier tube 202, a filament 204, a housing 206, an anchorassembly 208, a sealing member 210, a compaction member 212, and an autocompaction assembly 214. The carrier tube 202 may be advanced through aprocedure sheath 216 and be connected to the insertion sheath with aplurality of connectors 215. The auto compaction assembly 214 mayoperate to automatically advance the compaction member 212 relative tothe carrier tube 202 and procedure sheath 216 upon withdrawal of thehousing 206 to compact the sealing member 210 toward the anchor assembly208. The sealing member 210 may seal closed a tissue puncture 118 (seeFIGS. 6-10) and sandwich a portion of a wall of a vessel 128 between theanchor assembly 208 and sealing member 210. While an automaticallyoperating compaction assembly 214 is shown and described herein, othertypes of compaction assemblies, devices and methods may be used with theanchor assembly 208.

The anchor assembly 208 may include a first anchor portion 240 and asecond anchor portion 242. The first anchor portion 240 may include abase 244, a plurality of petal members 246A-D, hinge members 248operable between the base 244 and petal members 246A-D, and proximal anddistal surfaces 250, 252 (see FIGS. 11-13). The base 244 may include anaperture 254 and a first tapered surface 256 leading to and defining, atleast in part, the aperture 254. The first tapered surface 256 may beformed in the distal surface 252 and arranged to interface with aportion of the second anchor portion 242. In one example, the firsttapered surface 256 includes a tapered angle that matches a taperedangle of an second tapered surface 270 of the second anchor portion 242(see FIG. 7).

The petal members 246A-D may be connected to the base 244 at spacedapart locations around a periphery of the base 244. In somearrangements, the petal members 246A-D are equally spaced apart fromeach other, while in other arrangements, the petal members 246A D areunequally spaced apart. The petal members 246A-D may have substantiallythe same size and shape. The petal members 246A-D may be connected tothe base 244 using hinges 248. The hinge 248 may include a groove 264and a protrusion 266. A construction of the hinge 248 may permit thepetal members 246A-D to pivot or bend in a single direction relative tothe base 244 (e.g., in a proximal direction as shown in FIG. 6). Oncethe petal members 246A-D rotate from a retracted or pivoted position asshown in FIG. 6 to an expanded or extended position as shown in FIGS.7-10, the petal members 246A-D do not pivot further in the distaldirection. The petal members 246A-D may act as anchors within the vessel128 to limit movement of the anchor assembly 208 back through the tissuepuncture 118.

The petal members 246A-D may each include a neck portion 258, a petalportion 260, and a rib 262. The neck 258 may have a smaller width than amaximum width of the petal portions 260 (see FIGS. 11-12). The neck 258may connect to the hinges 248. The petal portions 260 may have anincreased surface area to provide improved contact and interface with aninner surface of the vessel adjacent to the tissue puncture 118. Thepetal portions 260 may be configured to at least partially bend or foldalong a longitudinal axis X (see FIG. 11) of each petal portion toassist in positioning the petal members 246A-D within the carrier tube202 (see FIG. 6). The rib 262 may provide additional rigidity for eachof the petal portions 260 once the first anchor portion 240 is removedfrom the carrier tube 202 so that the petal members 246A-D remain in anexpanded position as shown in FIGS. 7-14 without collapsing distally.The rib 262 may extend around an entire periphery of each of the petalportions 260. The rib 262 may extend along portions of the neck 258 andmay terminate at the hinge 248. In some arrangements, the rib 262 mayextend around only portions of the periphery of the first anchor portion240, or at other location spaced inward from the periphery.

In other embodiments, the petal portion 260 and a neck 258 may have aconstant width instead of having an increased width along the petalportions 260. The rib 262 may extend along different or additionalportions of the neck 258 and pedal portion 260 such as, for example, atleast one rib that extends parallel with and adjacent to the axis X.

The groove 264 and protrusion 266 of the hinge 248 may assist inproviding pivotal movement of the petal members 246A-D into a retractedposition relative to the base 244 in a single direction. The groove 264may provide a reduced resistance to bending in the neck 258 that permitsthe petal members 246A-D to bend or pivot in a proximal direction forpurposes of delivery of the first anchor portion 240 through the tissuepuncture 118. The protrusion 266 may provide an increased resistance topivoting or bending in the distal direction so that the first anchorportion 240 may provide an anchor function when expanded within thevessel 128.

The first anchor portion 240 has a maximum width W₁ when in the expandedposition as shown in FIG. 12. Typically, the maximum width W₁ is greaterthan a maximum width of the tissue puncture 118. The first anchorportion 240 has a minimum width W₂ when in a retracted or compactedposition when positioned within the carrier tube 202 (see FIG. 6). Theretracted position for the first anchor portion 240 may also be referredto as a low profile position or low profile orientation used fordelivery of the anchor assembly 208.

The first anchor portion 240 may be formed using a molding technique andmay have a generally solid construction. Alternatively, the first anchorportion 240 may comprise a skeleton construction having a minimum amountof material. In a skeleton construction embodiment (e.g., the firstanchor portion 440 shown in FIGS. 16-17), the petal members may bedefined by a perimeter piece of material with a hollow interior portion.The first anchor portion may comprise a shape memory material such as,for example, Nitinol or a shape memory polymer.

The first anchor portion may have any desired number of petal portions,FIG. 15 shows one alternative embodiment of a first anchor portion 340that includes first and second petal members 346A-B attached to a base344. The first and second petal members 346A-B may be arranged directlyopposite from each other and equally spaced around a periphery of thebase 344. Other arrangements are possible including unequal spacing ofthe petal members 346A-B around a periphery of the base 344.

The petal members 346A-B may include suture holes 363. The suture holes363 may be formed in the petal members 346A-B or on the base 344. Thesuture holes 363 may be used as alternative suture paths for suturespassing through the first anchor portion 340 rather than passing throughaperture 354 of base 344.

FIGS. 16-17 illustrate another example first anchor portion 440 thatincludes a base 444 and three petal members 446A-C. The petal members446A-C may be equally spaced apart around a periphery of the base 444.The first anchor portion 440 illustrates an example skeletalconstruction for the petal members 446A-C. The petal members 446 A-C mayhave a skeletal, frame-like structure and a hollow center. The base 444includes an aperture 454 and a tapered surface 456 configured to receivea second anchor portion 242.

Referring now to FIGS. 6-10 and 18-20, the second anchor portion 242includes a second tapered surface 270 and a suture aperture 272, and hasa maximum width W₃. The second tapered surface 270 may be formed to matewith the first tapered surface 256 of the first anchor portion 240. Asecond tapered surface 270 may be arranged facing proximally to face andcontact the distal surface 252 of the first anchor portion 240. Thesecond tapered surface 270 may include a generally conical or truncatedconical shape of the second anchor portion 242.

The suture aperture 272 may extend laterally through the second anchorportion 242. The suture aperture 272 may be sized to pass at least onesuture through the second anchor portion 242 to provide a physicalconnection of a suture to the second anchor portion 242.

The maximum width W₃ (see FIG. 20) is typically greater than a maximumwidth W₄ of the first tapered surface 256 (see FIG. 13) and the aperture254 of the first anchor portion 240. The second anchor portion 242, whendrawn against the first anchor portion 240 and mating with the firsttapered surface 256, plugs the aperture 254 to prevent fluid flow therebetween. The second tapered portion may be used to draw the first anchorportion 240 proximally into contact with an inner surface of the vessel128 adjacent to the tissue puncture 118.

Typically, the second anchor portion 242 has a relatively small heightH₁ (see FIG. 20) to minimize flow disruption within the vessel 128. Thesecond anchor portion 242 may comprise a different material than thefirst anchor portion 240. In one example, the second anchor portion 242comprises a rigid polymer such as polylactic-co-glycolic acid (PLGA).Both of the first and second anchor portions 240, 242 may comprise abioresorbable material such as a bioresorbable polymer.

The first and second anchor portions 240, 242 may include ananticoagulant coating such as, for example, heparin. Such a coating maylimit thrombosis in view of the large amount of material of the anchorassembly 208, especially provided with the plurality of petal members246A-D that are positioned within the vessel and exposed to blood flow.In some arrangements, anti-coagulant compounds may be embedded in thepolymer material prior to forming the first and second anchor portions240, 242. Other coatings are possible, including those that may increaseendothelization while also limiting thrombosis.

Referring now to FIGS. 6-10, an example method of sealing closed avessel puncture is described with reference to tissue puncture closuredevice 200. Referring first to FIG. 6, the procedure sheath 216 isadvanced through a percutaneous incision 119 and tissue puncture 118into a vessel 128. The carrier tube 202, which has positioned thereinthe anchor assembly 208, sealing member 210 and compaction member 212,is advanced through the procedure sheath 216 and into the tissuepuncture 118. The anchor assembly 208 is disposed out of the carriertube 202 and into the vessel 128 as shown in FIG. 7. The first anchorportion 240 may automatically move from the retracted, low profileposition within the carrier tube 202 shown in FIG. 6 to an expandedposition once expelled from the carrier tube 202 as shown in FIG. 7.

The filament 204 is connected to the second anchor portion 242. Thefilament 204 extends through the aperture 254 in the first anchorportion 240, through a weave pattern in the sealing member 210 definedby a plurality of holes 274, and extends proximal of the sealing member210 to the auto compaction assembly 214. A knot 205 may be formed in thefilament 204 and positioned proximal of and adjacent to the sealingmember 210. The knot 205 may be a slip knot which, when advanced alongthe filament 204, maintains pressure on the sealing member 210 andmaintains a position of the sealing member 210 relative to the filament204 and anchor assembly 208.

The entire tissue puncture closure device 200 may then be withdrawnuntil the first anchor portion 240 is pulled by the filament 204 againstan inner surface 129 of the vessel 128 by the second anchor portion 242.The one-way hinges 248 of the first anchor portion 240 are configured tolimit movement of the petal members 246A-D distally in order to maintainthe anchoring function against the inner surface 129.

The tissue puncture closure device 200 is withdrawn further in theproximal direction to activate the auto compaction assembly 214 toadvance the compaction member 212 to compact or compress the sealingmember 210 against the anchor assembly 208. The auto compaction assembly214 may concurrently retract the procedure sheath 216 and carrier tube202 while advancing the compaction member 212. The sealing member 210,when compacted as shown in FIG. 9, may fill the tissue puncture 118 andat least a portion of the percutaneous incision 119. The sealing member210 may absorb fluids such as any blood that is within the percutaneousincision 119 and expand to seal closed the tissue puncture 118. The knot205 may be advanced along the filament 204 while advancing thecompaction member 212. The knot 205 may help hold the sealing member 210in the compacted position shown in FIG. 9.

The auto compaction assembly 214 may then be disengaged so that thecarrier tube 202, compaction member 212, and procedure sheath 216 may beremoved from the patient. The filament 204 is cut as shown in FIG. 10.

Some example auto compaction assemblies that are suitable for use withthe closure device 200 are described in U.S. Pat. Nos. 7,931,670;7,618,438; and 7,250,057, which patents are incorporated herein in theirentireties by this reference.

The tissue puncture closure device 200 is configured to seal closed avessel puncture using a two-piece anchor assembly that is positionedwithin a vessel and a compaction assembly that sandwiches a wall of thevessel between a sealing member that is positioned outside of the vesseland the anchor assembly. A first portion of the anchor assembly (alsoreferred to as plug) has a suture attached thereto with the sutureextending through an aperture in the other anchor portion. Applyingtension to the suture draws the plug against a seat in the other anchorportion and against an internal wall of the vessel. An interface betweenthe two anchor portions may provide a fluid-tight configuration for theanchor assembly and may temporarily seal closed a vessel puncture whenthe anchor assembly is drawn against an internal surface of the vesseland overlapping the vessel puncture. The first anchor portion mayisolate the second anchor portion from contracting the vessel.

The anchor assembly may operate between a retracted, low profileposition when delivered through the vessel puncture, and an expandedlarge profile position to provide an anchor function within the vessel.The anchor assembly may be particularly useful for large bore closuresof at least 10 French in size.

While this invention has been described with reference to certainspecific embodiments and examples, it will be recognized by thoseskilled in the art that many variations are possible without departingfrom the scope and spirit of this invention. The invention, as definedby the claims, is intended to cover all changes and modifications of theinvention which do not depart from the spirit of the invention.

1-20. (canceled)
 21. A method of closing a vessel opening in a vesselwall of a vessel, the method comprising: providing an anchor assembly, asuture, and a sealing member, the anchor assembly including a firstanchor member having a plurality of petals movable between an expandedposition and a retracted position, the plurality of petals having afirst width in the retracted position, and a second anchor memberconnected to the suture, the second anchor member having a second width,the second width being about equal to the first width; advancing theanchor assembly through the vessel opening and into the vessel; movingthe plurality of petals into the expanded position; retracting thesecond anchor member to draw the first anchor member against an innersurface of the vessel wall; advancing the sealing member to the vesselopening to seal closed the vessel opening.
 22. The method of claim 21,wherein moving the plurality of petals into the expanded position occursautomatically upon deploying the first anchor member within the vessel.23. The method of claim 21, further comprising providing a carrier tubeand positioning the anchor assembly within the carrier tube for deliveryinto the vessel.
 24. The method of claim 21, further comprising pivotingthe plurality of petals proximally into the retracted position beforeadvancing the anchor assembly through the vessel opening.
 25. The methodof claim 21, further comprising pivoting the plurality of petals throughan angle of no greater than about 100° between the expanded andretracted positions.
 26. The method of claim 21, wherein each of theplurality of petals comprises a periphery and wherein each of theplurality of petals comprises a stiffening rib extending around theperiphery.
 27. The method of claim 21, wherein the plurality of petalsextend perpendicular to a longitudinal axis of the anchor assembly inthe expanded position.
 28. A method of sealing a vessel puncture in avessel wall of a body vessel, the method comprising: providing an anchorassembly, a suture, and a carrier tube, the anchor assembly comprising afirst anchor portion and a second anchor portion, the suture beingconnected to the second anchor portion, the first anchor portion havingan expanded configuration and a retracted configuration; advancing adistal end of the carrier tube into an interior of the vessel wall withthe anchor assembly positioned in the carrier tube and the first anchorportion being in the retracted configuration; moving the anchor assemblyout of the carrier tube; automatically moving the first anchor portionfrom the retracted configuration into the expanded configuration;drawing the second anchor portion against the first anchor portion,thereby drawing the first anchor portion against the vessel wall. 29.The method of claim 28, wherein the first anchor portion comprises aplurality of petals and moving the first anchor portion from theretracted configuration into the expanded configuration comprises movingthe plurality of petals from a generally longitudinally-orientedposition to a generally radially-oriented position relative to thesuture.
 30. The method of claim 28, wherein the second anchor portion isdrawn into a recess in the first anchor portion.
 31. The method of claim30, wherein the second anchor portion comprises a truncated conicalshape and the truncated conical shape is drawn into the recess in thefirst anchor portion.
 32. The method of claim 28, wherein the secondanchor portion mates with a tapered surface of the first anchor portion.33. The method of claim 32, wherein the tapered surface of the firstanchor portion comprises a taper angle and the second anchor portioncomprises a second tapered surface comprising the taper angle.
 34. Themethod of claim 28, wherein the suture extends through the first anchorportion to connect to the second anchor portion, and moving the firstanchor portion from the retracted configuration into the expandedconfiguration comprises pivoting the first anchor portion relative tothe suture.
 35. The method of claim 28, wherein drawing the first anchorportion against the vessel wall seals the vessel puncture.
 36. Themethod of claim 28, further comprising compacting a sealing membertoward the anchor assembly.
 37. The method of claim 28, wherein thefirst anchor portion has a first width in the expanded configuration andthe carrier tube has a second width, the first width being greater thanthe second width.
 38. The method of claim 28, wherein the suture extendsthrough a central aperture in the second anchor portion.
 39. A method ofsealing a vessel puncture in a vessel wall of a body vessel, the methodcomprising: providing an anchor assembly and a suture, the anchorassembly comprising a first anchor portion and a second anchor portion,the suture being connected to the second anchor portion, the firstanchor portion having a plurality of petal members, the plurality ofpetal members being pivotable relative to each other; positioning thefirst anchor portion within the vessel wall of the body vessel; pivotingthe plurality of petal members relative to each other into an expandedconfiguration; proximally drawing the suture to draw the second anchorportion against the first anchor portion, thereby drawing the firstanchor portion against the vessel wall.
 40. The method of claim 39,wherein the plurality of petal members are each pivotally connected to abase of the second anchor portion, and drawing the second anchor portionagainst the first anchor portion comprises drawing the second anchorportion into contact with the base.